# Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
> **Food and Drug Administration** · Final rule. · Published 2004-05-25 · Effective 2005-05-25 · 69 FR 29786
## Document
- **Document number:** 04-11245
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 29786
- **CFR reference:** 21 CFR 210
- **Publication date:** 2004-05-25
- **Effective date:** 2005-05-25
- **HHS docket:** Docket No. 1997N-0484S
## Abstract

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT[sol]P) establishments to screen and test cell and tissue donors for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. The agency is amending the current good manufacturing practice (CGMP) and quality system (QS) regulations that apply to HCT[sol]Ps regulated as drugs, medical devices, and/or biological products to clarify the role of the new donor-eligibility regulations in relation to existing CGMP regulations. By preventing the transmission of communicable disease by the wide spectrum of HCT[sol]Ps that are marketed now or may be marketed in the future, the agency's action will improve protection of the public health and increase public confidence in new technologies.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/05/25/04-11245/eligibility-determination-for-donors-of-human-cells-tissues-and-cellular-and-tissue-based-products)
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